N/A N=32 Treatment

Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients

Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT02246777 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Mean Intraocular Pressure (IOP) — 9.4; 9.5; 10.0 mmHG

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ex-PRESS® Glaucoma Filtration Device, Model P50PL (Device)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Intraocular Pressure (IOP)	9.4; 9.5; 10.0	—
PRIMARY Change From Baseline in IOP	-5.4; -5.4; -4.9	—
PRIMARY Percent Change From Baseline in IOP	-35.4; -33.7; -31.1	—
PRIMARY Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12	72.4; 82.1; 61.5	—
PRIMARY Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP	0.0; 0.0; 3.2	—
PRIMARY Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP	88; 12; 0; 0; 0; 94	—

Summary

The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.

Eligibility Criteria

Inclusion Criteria

Diagnosis of normal tension glaucoma.
Indicated for filtration surgery using Ex-PRESS®.
Understand and provide Informed Consent.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Women who are pregnant, lactating, or planning to be pregnant during the study period.
Diagnosis of angle closure glaucoma or secondary glaucoma.
History of glaucoma surgery.
Ophthalmologic surgery within the past 6 months.
Difficulty with applanation tonometry measurement.
Corneal dystrophy.
Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
Severe blepharitis or dry eye.
History of metal allergy.
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02246777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.